Cleared Dual Track

K214117 - Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K214117 · Abbott Diagnostics Technologies AS · Chemistry device
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Optimized for regulatory review, auditing and printing
Sep 2023
Decision
636d
Days
Class 2
Risk

K214117 is an FDA 510(k) clearance for the Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Abbott Diagnostics Technologies AS (Oslo, NO). The FDA issued a Cleared decision on September 27, 2023 after a review of 636 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Abbott Diagnostics Technologies AS devices

Submission Details

510(k) Number K214117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2021
Decision Date September 27, 2023
Days to Decision 636 days
Submission Type Dual Track
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
548d slower than avg
Panel avg: 88d · This submission: 636d
Pathway characteristics

Device Classification

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.